Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-29 @ 8:37 AM
Study NCT ID:
NCT00872612
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
2009-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial for the Diagnosis of Sarcoidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-04', 'studyFirstSubmitDate': '2009-03-30', 'studyFirstSubmitQcDate': '2009-03-30', 'lastUpdatePostDateStruct': {'date': '2015-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB)', 'timeFrame': 'within a week'}], 'secondaryOutcomes': [{'measure': 'Assessment of complications of both the endosonography and conventional bronchoscopic workup', 'timeFrame': 'within 30 days'}, {'measure': 'The additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis', 'timeFrame': '2 weeks'}, {'measure': 'Assessment of patient preference for both the endosonographic and conventional bronchoscopic work-up.', 'timeFrame': 'within a week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sarcoidosis', 'Diagnosis', 'Non-caseating granulomas', 'BAL', 'EUS-FNA', 'EBUS-TBNA', 'TBLB'], 'conditions': ['Sarcoidosis']}, 'referencesModule': {'references': [{'pmid': '10573213', 'type': 'BACKGROUND', 'citation': 'Costabel U, Hunninghake GW. ATS/ERS/WASOG statement on sarcoidosis. Sarcoidosis Statement Committee. American Thoracic Society. European Respiratory Society. World Association for Sarcoidosis and Other Granulomatous Disorders. Eur Respir J. 1999 Oct;14(4):735-7. doi: 10.1034/j.1399-3003.1999.14d02.x. No abstract available.'}, {'pmid': '18032765', 'type': 'BACKGROUND', 'citation': 'Iannuzzi MC, Rybicki BA, Teirstein AS. Sarcoidosis. N Engl J Med. 2007 Nov 22;357(21):2153-65. doi: 10.1056/NEJMra071714. No abstract available.'}, {'pmid': '8339618', 'type': 'BACKGROUND', 'citation': 'Winterbauer RH, Lammert J, Selland M, Wu R, Corley D, Springmeyer SC. Bronchoalveolar lavage cell populations in the diagnosis of sarcoidosis. Chest. 1993 Aug;104(2):352-61. doi: 10.1378/chest.104.2.352.'}, {'pmid': '9493649', 'type': 'BACKGROUND', 'citation': 'Kantrow SP, Meyer KC, Kidd P, Raghu G. The CD4/CD8 ratio in BAL fluid is highly variable in sarcoidosis. Eur Respir J. 1997 Dec;10(12):2716-21. doi: 10.1183/09031936.97.10122716.'}, {'pmid': '15738281', 'type': 'BACKGROUND', 'citation': 'Annema JT, Veselic M, Rabe KF. Endoscopic ultrasound-guided fine-needle aspiration for the diagnosis of sarcoidosis. Eur Respir J. 2005 Mar;25(3):405-9. doi: 10.1183/09031936.05.00098404.'}, {'pmid': '17890467', 'type': 'BACKGROUND', 'citation': 'Garwood S, Judson MA, Silvestri G, Hoda R, Fraig M, Doelken P. Endobronchial ultrasound for the diagnosis of pulmonary sarcoidosis. Chest. 2007 Oct;132(4):1298-304. doi: 10.1378/chest.07-0998. Epub 2007 Sep 21.'}, {'pmid': '23780458', 'type': 'DERIVED', 'citation': "von Bartheld MB, Dekkers OM, Szlubowski A, Eberhardt R, Herth FJ, in 't Veen JC, de Jong YP, van der Heijden EH, Tournoy KG, Claussen M, van den Blink B, Shah PL, Zoumot Z, Clementsen P, Porsbjerg C, Mauad T, Bernardi FD, van Zwet EW, Rabe KF, Annema JT. Endosonography vs conventional bronchoscopy for the diagnosis of sarcoidosis: the GRANULOMA randomized clinical trial. JAMA. 2013 Jun 19;309(23):2457-64. doi: 10.1001/jama.2013.5823."}]}, 'descriptionModule': {'briefSummary': 'This randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage I/II.\n\nThe objective is to assess the role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB).\n\nAlso the researchers investigate the additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis.\n\nThirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup.', 'detailedDescription': 'Sarcoidosis is the most prevalent interstitial lung disease in Western-Europe and the US. The disease is most prevalent in young adults. To set the final diagnosis of sarcoidosis, the following parameters need to be present:\n\n1. A clinical and radiological suspicion of sarcoidosis stage I/II.\n2. A tissue diagnosis of disease-specific non-caseating granulomas.\n3. Exclusion of possible alternative diagnoses as lung cancer or tuberculosis.\n\nNowadays, a bronchoscopy with lung biopsies is advised to set a tissue diagnosis of sarcoidosis. However, these biopsies are only diagnostic in 70% of the procedures and they are associated with a 3% risk of coughing up blood and a 4% risk of a lung collapse.\n\nSince recently, a new diagnostic procedure has come available. This procedure, endo-sonography, makes it possible to biopsy lymph nodes in the chest under direct visualization and has a diagnostic accuracy of 85%. The associated risk of complications appears to be small (\\<1%)\n\nWe consider the current standard for the diagnostics of sarcoidosis to be outdated, considering the clinical availability of endo-sonography. We expect that endo-sonography is more frequent diagnostic for a tissue diagnosis of sarcoidosis.\n\nAlso we hypothesize that this technique is safer and more preferred by patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with suspected pulmonary sarcoidosis stage I/ II\n* Age \\> 18 years\n* Both males and females\n* Written informed consent is obtained.\n\nExclusion Criteria:\n\n* Patients with obvious other organ involvement of sarcoidosis where a simple diagnostic biopsy to assess granulomas can be performed.\n* Löfgren's syndrome\n* Inability to undergo fiberbronchoscopy, EBUS or EUS (e.g. respiratory insufficiency, esophageal stenosis\n* Contraindications for a lung or nodal biopsy (e.g. coagulopathy, thrombocytopenia)\n* Pregnancy\n* Inability to obtain informed consent"}, 'identificationModule': {'nctId': 'NCT00872612', 'acronym': 'GRANULOMA', 'briefTitle': 'Trial for the Diagnosis of Sarcoidosis', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial', 'orgStudyIdInfo': {'id': 'LUMC-GRANULOMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Endosonography arm', 'interventionNames': ['Procedure: EUS-FNA/EBUS-TBNA + BAL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Conventional bronchoscopy arm', 'interventionNames': ['Procedure: EBB + TBLB + BAL']}], 'interventions': [{'name': 'EUS-FNA/EBUS-TBNA + BAL', 'type': 'PROCEDURE', 'description': 'EUS-FNA = Endoscopic Ultrasound guided fine needle aspiration of mediastinal lymph nodes.\n\nEBUS-TBNA = Endobronchial Ultrasound guided transbronchial needle aspiration of mediastinal and hilar lymph nodes.\n\nBAL = bronchoalveolar lavage', 'armGroupLabels': ['A']}, {'name': 'EBB + TBLB + BAL', 'type': 'PROCEDURE', 'description': 'EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '2900', 'city': 'Hellerup', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Gentofte Hospital Copenhagen', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '69126', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Thoraxklinik Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '22927', 'city': 'Großhansdorf', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Hospital Grosshansdorf', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'city': 'Arnhem', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Rijnstaete Ziekenhuis', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud Universitair Medisch Centrum', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'St. Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '2300 RC', 'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Pulmonary Department, Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '3015 CE', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medisch Centrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'St. Franciscus Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'The Hague', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Medisch Centrum Haaglanden', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'University hospital Krakow, J.P. II', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Zakopane', 'country': 'Poland', 'facility': 'Sokołowski Pulmonary Hospital', 'geoPoint': {'lat': 49.29899, 'lon': 19.94885}}, {'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'M B von Bartheld, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pulmonary Department, Leiden University Medical Center'}, {'name': 'J T Annema, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonary Department, Leiden University Medical Center'}, {'name': 'K F Rabe, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonary Department, Leiden University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MB von Bartheld, MSc. PhD Student', 'investigatorFullName': 'M.B. von Bartheld', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}